Electrocardiographic Mapping and Imaging

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01394965
Recruitment Status : Withdrawn
First Posted : July 15, 2011
Last Update Posted : October 21, 2013
University of Minnesota - Clinical and Translational Science Institute
Information provided by (Responsible Party):
Samuel J. Asirvatham, Mayo Clinic

Brief Summary:
The purpose of this study is to evaluate a novel non-invasive cardiac electric imaging methodology for localizing and imaging cardiac electrical activity from body surface electrocardiographic recordings in patients with ventricular tachycardia (VT). Using non-invasive means will increase our ability to correctly diagnose cardiac abnormalities, and aid ablation of cardiac arrhythmias, offering enhanced performance to what currently exists.

Condition or disease Intervention/treatment Phase
Cardiac Arrhythmia Procedure: ECG electrodes Early Phase 1

Detailed Description:

Specific Aims

1. Use non-invasive cardiac electric imaging to provide information as to the sites of origin of arrhythmias and sequence of cardiac activation and repolarization.

Methods and Procedures Approximately 8 patients with recorded Premature Ventricular Contractions (PVC), Wolff-Parkinson-White (WPW) or other ventricular tachycardia cases which need Ensite/Carto endocardial mapping and radiofrequency ablation treatment will be enrolled.

One day before catheterization and ablation, patients will undergo approximately 30 minutes of Body Surface Potential Mapping (BSPM) recordings with about 200 surface electrodes arranged in 20 strips, attached on his/her front and back. BSPMs will be recorded in the baseline resting rhythm.

On the day of ablation, before catheterization in the surgical room, the BSPM recording procedure will be carried out with the patient using the same technique used during the first BSPM study.

Clinical endocardial mapping data may also be obtained concurrently with BSPM recordings before the ablation procedure.

Another BSPM recording will be made 30-60 minutes after successful ablation with the patient still in normal sinus rhythm if possible. Patients will be followed up 1 month after ablation with the same method of BSPM recorded at the baseline resting rhythm.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Official Title: Electrocardiographic Mapping and Imaging
Study Start Date : October 2013
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Arrhythmia
U.S. FDA Resources

Arm Intervention/treatment
No Intervention: ECG Mapping Procedure: ECG electrodes
Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.
Other Names:
  • Electrode strips
  • Electrode patches

Primary Outcome Measures :
  1. Results of ECG Mapping [ Time Frame: 1 year ]
    Accuracy of the system to estimate site of arrhythmia origin, and frequency of obtaining ecg signals

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Any patient undergoing ablation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01394965

United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
University of Minnesota - Clinical and Translational Science Institute
Principal Investigator: Samuel Asirvatham, MD Mayo Clinic

Responsible Party: Samuel J. Asirvatham, PI, Mayo Clinic Identifier: NCT01394965     History of Changes
Other Study ID Numbers: 10-004825
First Posted: July 15, 2011    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Samuel J. Asirvatham, Mayo Clinic:
ecg mapping

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes